FDA clears a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejecti...
Federal Register notice: FDA announces a 7/18-19 Blood Products Advisory Committee.
FDA clears a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system.
FDA clears a Caliber Imaging & Diagnostics 510(k) for modifications to its Vivascope System, a reflectance confocal microscopy device.
FDA approves a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgens Epogen/Procrit (epoetin alfa) for treating anemia ...
Federal Register proposed rule: FDA proposes to amend its regulations concerning the classification of products as biologics, devices, drugs, or combi...
The University of Illinois at Chicago College of Pharmacy suggests FDA take five steps to speed development and approval of biosimilars.
Three stakeholders raise concerns and questions about FDA-proposed research surveying healthcare professionals on aspects of prescription drug promoti...